Infectious diseases report 2013

Description

Biopharmaceutical Research Evolves Against
Infectious Diseases with Nearly 400 Medicines
and Vaccines in Testing.

Throughout history, infectious diseases
have taken a devastating toll on the lives
and well-being of people around the
world. Caused when pathogens such
as bacteria or viruses enter a body and
multiply, infectious diseases were the
leading cause of death in the United
States until the 1920s. Today, vaccines
and infectious disease treatments have
proven to be effective treatments in
many cases, but infectious diseases still
pose a very serious threat to patients.

Infectious Diseases A Report on Diseases Caused by Bacteria, Viruses, Fungi and Parasites PRESENTED BY AMERICA’S BIOPHARMACEUTICAL RESEARCH COMPANIES Biopharmaceutical Research Evolves Against Infectious Diseases with Nearly 400 Medicines and Vaccines in Testing Medicines in Development For Infectious Diseases Application Submitted Phase III Phase II Phase I 226 America’s biopharmaceutical research companies are developing 394 medicines and vaccines to combat the many threats posed by infectious diseases. Each of these medicines in development is either in clinical trials or under review by the Food and Drug Administration (FDA). 124 Some examples of potential medicines for ﬁghting infectious diseases include: • A combination treatment for the most common and difﬁcult to treat form of Ot l 8 Vir a ic sit l Pa ra ga Fu n l cte ria 15 he r Among the medicines and vaccines in development are 226 for viral infections, such as hepatitis, herpes and human papillomavirus (HPV); 124 for bacterial infections, such as pneumonia and tuberculosis; 24 for fungal infections and 15 for parasitic infections. 24 Ba Throughout history, infectious diseases have taken a devastating toll on the lives and well-being of people around the world. Caused when pathogens such as bacteria or viruses enter a body and multiply, infectious diseases were the leading cause of death in the United States until the 1920s. Today, vaccines and infectious disease treatments have proven to be effective treatments in many cases, but infectious diseases still pose a very serious threat to patients. Recently, some infectious pathogens, such as pseudomonas bacteria, have become resistant to available treatments. Diseases once considered conquered, such as tuberculosis, have reemerged as a growing health threat. hepatitis C that inhibits the enzyme essential for viral replication. • An anti-malarial drug that has shown activity against Plasmodium falciparum malaria which is resistant to current treatments. • A potential new antibiotic to treat methicillin-resistant Staphylococcus aureus (MRSA). • A novel treatment that works by blocking the ability of the smallpox virus to spread to other cells, thus preventing it from causing disease. Infectious diseases may never be fully eradicated. However, new knowledge, new technologies, and the continuing commitment of America’s biopharmaceutical research companies can help meet the continuing—and ever-changing —threat from infectious diseases. Contents Innovative Medicines/Vaccines in the Pipeline .................................2 Key Medicine/Vaccine Approvals........3 Preventative Vaccines .......................5 Drug-Resistant Infectious Diseases .... 6 Facts About Infectious Diseases .........7 Medicines/Vaccines in Development ................................. 9 Glossary .......................................42 Drug Development/ Approval Process .......................... 46 2013 REPORT MEDICINES IN DEVELOPMENT

Key Issues Innovative Medicines and Vaccines in the Pipeline Bacterial Diarrhea—About 3 million cases of Clostridium difﬁcile-associated diarrhea (CDAD) occur each year in the United States. CDAD is caused by an overgrowth of the gram-positive bacteria naturally found in the lower gastrointestinal tract. An antibacterial lipopeptide in development for the treatment CDAD has a more rapid antibacterial action than available treatments. Hepatitis C—Hepatitis C virus (HCV) affects 180 million people worldwide, including more than 4 million Americans, according to the National Institute of Allergy and Infectious Diseases. The Centers for Disease Control and Prevention (CDC) projects that the death toll in the United States from hepatitis C will triple in the next 20 years, eclipsing that of AIDS. A potential medicine is in development in a combination treatment for HCV genotype 1—the most common and difﬁcult to treat form of HCV—is an inhibitor of the hepatitis C virus NS5B—a virally encoded enzyme that is essential for viral replication. HIV Infection—A therapeutic vaccine in development is targeting the low-mutating (conserved) parts from the protein p24 of the HIV virus. The vaccine consists of four peptides that are modiﬁed to increase the immune response against INFECTIOUS DISEASES RESEARCH & DEVELOPMENT 394 MEDICINES AND VACCINES IN DEVELOPMENT AGAINST INFECTIOUS DISEASES Source: PhRMA 2013 Medicines in Development for Infectious Diseases 2 ANTIBIOTIC I N F E C RESISTANT T I O N S AFFECT 2 MILLION+ AMERICANS ANNUALLY Source: Centers for Disease Control and Prevention (CDC) the conserved parts of the p24 protein. A sustained immune response against the p24 protein has shown to be associated with delayed disease progression. Impetigo—Impetigo is a highly contagious skin infection caused by the Staphylococcus aureus bacteria entering a small break in the skin, such as a cut, scratch or insect bite. It affects approximately 1 million people annually in the United States, primarily infants and children, and causes itchy and painful sores. A novel synthetic antimicrobial medicine in development is speciﬁcally designed and developed to mimic the body’s natural defense against infection. In clinical trials, the clinical response rate in patients at the end of treatment ranged from 85 percent to 92 percent compared to historical placebo rates of 30 percent to 50 percent. Malaria—Globally, about 275 million cases of malaria are diagnosed each year, killing more than 1 million people—about 3,000 people every day, according to the World Health Organization. A novel anti-malarial drug in development has shown activity against Plasmodium falciparum malaria that is resistant or sensitive to chloroquine, a common malaria treatment. Multi-Drug Resistant (MDR) Infection—Multi-drug resistance occurs when a bacteria develops the ability to survive exposure to more than one available therapy. The incidence of drug-resistant strains of Staphylococcus aureus has recently Medicines in Development Infectious Diseases 2013

Key Issues been on the rise. According to the CDC, more than 90,000 Americans become infected each year with life-threatening drug-resistant staph—methicillin-resistant Staphylococcus aureus, or MRSA. A novel medicine in development inhibits the beta lactamase enzyme produced by various types of bacteria which can provide resistance to some antibiotics. The medicine is being studied in combination with a broad spectrum cephalosporin for the treatment of MRSA—for both gram-negative and gram-positive bacteria. Another medicine in development to combat MRSA is in a new class of antibiotics called aminomethylcyclines. In testing, it has demonstrated broad-spectrum antibacterial activity and particularly potent activity against gram-positive bacteria that are resistant to existing antibacterials. Smallpox (Orthopoxvirus Infections)—Smallpox, caused by the variola virus, is no longer found in the environment, but is considered a formidable biowarfare threat. A novel treatment in development works by blocking the ability of the virus to spread to other cells, thus preventing it from causing disease. It is being studied to prevent the disease in non-vaccinated individuals, to treat the disease in nonsymptomatic people exposed to smallpox, to treat those with smallpox symptoms, and as an adjuvant to vaccination by combining with smallpox vaccines to prevent disease and reduce vaccine-related complications. ANTIBIOTIC I N F E C RESISTANT T I O N CAUSE ~23,000 DEATHS ANNUALLY Source: Centers for Disease Control and Prevention (CDC) Medicines in Development Infectious Diseases 2013 S RESEARCH FOCUS: HEPATITIS C Hepatitis C is a viral disease that attacks the liver, leading to many complications, including cirrhosis, liver transplants, liver cancer and death. It affects about 3.2 million people in the United States. The rate of detectable hepatitis C virus in the blood 24 weeks after treatment improved from 10 percent in the 1990s to 80 percent today among hepatitis C patients. This increase reﬂects growing knowledge of the disease and treatments that moved towards today’s triple therapy regimens, which include recently approved “direct acting antivirals.” Key Medicine and Vaccine Approvals Fungal Infections Noxaﬁl® (posaconazole) was approved for the prevention of invasive fungal infections caused by Aspergillus and Candida in patients 13 years of age and older who are at high risk of developing these infections due to being severely immunocompromised. It is the ﬁrst and only antifungal approved by the FDA for the prevention of invasive fungal infections caused by Aspergillus. Invasive fungal infections most often occur in people who are immunocompromised or immunosuppressed and are increasingly caused by molds such as Aspergillus. Mycamine™ (micafungin sodium for injection), an antifungal, was approved for the prevention of Candida infections in patients undergoing hematopoietic stem cell transplantation and the treatment of esophageal candidiasis. The medicine is a member of a new class of antifungal agents called echinocandins, which speciﬁcally targets the wall of fungal cells to treat the infection. Hepatitis Victrelis™ (boceprevir) is a ﬁrst-in-class medicine approved for the treatment of chronic hepatitis C in combination with interferon therapy for those with compensated liver disease. Victrelis is a hepatitis C protease inhibitor, which works by inhibiting a key viral enzyme and preventing the virus from multiplying. Baraclude™ (entecavir) was approved for the treatment of chronic hepatitis B in adults with evidence of active viral replication and either evidence of persistent elevations in 3

Key Issues serum aminotransferases or histologically active disease. The drug is an oral antiviral that is designed to block the replication of hepatitis B virus in the body by interfering with the virus’s ability to infect cells. HIV Infection Intelence™ (etravirine) is the ﬁrst non-nucleoside reverse transcriptase inhibitor (NNRTI) to show antiviral activity in patients with NNRTI-resistant virus. It was approved for the treatment of HIV infection, in combination with other antiretroviral agents, in treatment-experienced adult patients who have evidence of viral replication and resistance to NNRTI and other antiretroviral agents. Isentress™ (raltegravir) was approved for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-experienced adult patients who have evidence of viral replication and resistance to multiple antiretroviral agents. Isentress is the ﬁrst in a new class of antiretroviral drugs known as integrase inhibitors. It is designed to interfere with the enzyme that delivers HIV viral DNA into human DNA, thereby limiting the ability of HIV to replicate and infect new cells. Selzentry™ (maraviroc) is the ﬁrst new medicine in the class of HIV medicines—known as CCR5 antagonists—in more ANTIBIOTIC I F N E 1 1 $ 1 1 1 1 $ 1 1 1 1 $ 1 1 $ 1 1 1 1 $ 1 1 1 1 1 1 $ 1 1 1 1 $ 1 1 1 1 $ 1 1 1 1 $ 1 1 $ 1 1 1 1 1 1 $ 1 1 1 1 $ 1 1 1 1 1 1 RESISTANT C 1 1 1 1 $ $ 1 1 1 1 T 1 1 1 1 $ $ 1 1 1 1 I O N 1 1 1 1 $ $ 1 1 1 1 S 1 1 1 1 $ 1 1 1 1 $ 1 1 $ 1 1 ACCOUNT FOR 1 1 $ 1 1 1 1 $ 1 1 1 1 $ 1 1 1 1 $ 1 1 1 1 $ 1 1 1 1 $ 1 1 1 1 $ 1 1 1 1 $ 1 1 1 1 1 1 $ 1 1 1 1 $ 1 1 1 1 $ 1 1 1 1 $ 1 1 1 1 $ 1 1 1 1 $ 1 1 $ 1 1 1 1 $ 1 1 1 1 $ 1 1 1 1 $ 1 1 1 1 $ 1 1 1 1 $ 1 1 1 1 $ 1 1 $ 1 1 1 1 $ 1 1 1 1 $ 1 1 1 1 $ 1 1 1 1 $ 1 1 1 1 $ 1 1 1 1 $ 1 1 $ 1 1 1 1 $ 1 1 1 1 $ 1 1 1 1 $ 1 1 1 1 $ 1 1 1 1 $ 1 1 1 1 $ 1 1 $20 BILLION IN DIRECT HEALTH CARE COSTS ANNUALLY Source: Centers for Disease Control and Prevention (CDC) than 10 years. Selzentry blocks the CCR5 co-receptor, the virus’ predominant entry into white blood cells (T-cells) by stopping the virus on the outside surface of the cells before it enters. It has been shown to signiﬁcantly reduce viral load and increase T-cell counts in treatment-experienced patients infected with a speciﬁc type of HIV. PROGRESS AGAINST HIV/AIDS: THE EVOLUTION OF VALUE FOR PATIENTS Over the past 20 years, research advances in HIV/AIDS have transformed the treatment standard for many patients. HIV/AIDS was once an acute, fatal illness and is now a manageable, chronic disease for those who have access to medications. In the United States alone, death rates have fallen more than 80 percent since 1995 as a result of the development and use of multiple drugs used in innovative combinations, known as highly active antiretroviral therapy (HAART). Progress against HIV/AIDS didn’t happened through one single breakthrough, but through a series of stages, marked by both the introduction of new treatment options and constant learning about their optimal use and clinical value. FDA approval, which is based on rigorous clinical trials in controlled settings, marks the starting point for the continuing evolution in our understanding of a treatment’s full value for patients. As is the case for HIV/AIDS, the full value of new treatments is often not fully known at the time of FDA approval, but is realized over time as new treatments build on one another and real world knowledge is accumulated. The ongoing introduction of new HIV/AIDS therapies, and continuous research into their optimal use in patient care, has revealed additional value for treatments beyond what was known at the time they were introduced. These include: • Use in combination with other therapeutics • Use earlier in treatment line or disease state • Use in treatment of different diseases, such as cancer 4 Medicines in Development Infectious Diseases 2013

Key Issues Inﬂuenza FluBlok® (inﬂuenza vaccine) is the ﬁrst recombinant, highly puriﬁed, egg-free inﬂuenza vaccine approved. The vaccine is manufactured without using live inﬂuenza virus and is 100 percent egg-free. The novel manufacturing method allows the vaccine to be made quickly and it does not rely on egg supply or available inﬂuenza virus. It is also preservative, antibiotic and adjuvant free. FluBlok was developed in partnership with the Biomedical Advanced Research and Development Authority (BARDA), a division of the U.S. Department of Health and Human Services. Flucelvax® (inﬂuenza virus vaccine) is the ﬁrst cell-culture derived vaccine approved to protect against seasonal inﬂuenza in adults. It is manufactured using full-scale cell-culture technology, an alternative to traditional egg-based production. Cell-culture technology uses a mammalian cell line rather than chicken eggs to grow virus strains. It does not contain any preservatives or antibiotics. In clinical trials, Flucelvax showed to be 83.8 percent effective in preventing the ﬂu when compared to placebo. Tuberculosis Sirturo™ (bedaquiline) received accelerated approval as a combination therapy for adults with multi-drug resistant pulmonary tuberculosis (MDR-TB). It is the ﬁrst new TB therapy in 40 years with a new mechanism of action. Sirturo inhibits mycobacterial ATP (adenosine 5’-triphosphate) synthase, an enzyme that is needed for the generation of energy in Mycobacterium tuberculosis. ANTIBIOTIC I N F E C RESISTANT T I O N ACCOUNT FOR $35 BILLION IN LOST PRODUCTIVITY ANNUALLY S INFECTIOUS R E S I S DISEASES T A N C E NEARLY 50% OF ANTIBIOTICS UNNECESSARILY or INAPPROPRIATELY PRESCRIBED Source: Centers for Disease Control and Prevention (CDC) Preventative Vaccines: Positive Impact to Health and Society Vaccines are one of the most profound achievements of biomedical science and public health. Spanning more than 200 years of research and development, 10 infectious diseases have been at least 90 percent eradicated in the United States thanks to vaccines. This has protected millions of children and families from preventable illness. The prevention of disease has an enormous impact on the health of individuals and communities overall, as well as a substantial impact on the economy by reducing health care costs and avoiding lost productivity. Preventative vaccines are given to individuals, but see their greatest beneﬁt when entire populations are immunized. When a high concentration of vaccination is attained in a community with an effective vaccine, disease transmission can be successfully disrupted. When disease transmission is disrupted, even those who were not vaccinated, or those who did not receive immunity from the vaccine, beneﬁt from vaccination and can be protected from the disease. This is known as herd immunity—where immunization coverage is sufﬁcient enough to prevent the transmission of a disease to the susceptible population. This is especially important for the young, the elderly and those with compromised immune systems. Source: Centers for Disease Control and Prevention (CDC) Medicines in Development Infectious Diseases 2013 5

Key Issues Drug-Resistant Infectious Diseases More than 2 million people in the United States get infections that are resistant to antibiotics and about 23,000 die as a result of the resistant infections, according to a new report from the CDC. While difﬁcult to calculate, the CDC report also cites the economic cost of antibiotic resistance to the U.S. economy as high as $20 billion in direct healthcare costs and another $35 billion in lost productivity (2008 dollars). “Antibiotic resistance is rising for many different pathogens that are threats to health. If we don’t act now, our medicine chest will be empty and we won’t have the antibiotics we need to save lives.” —Tom Frieden, MD, MPH, Director, CDC The new report—Antibiotic Resistance Threats in the United States, 2013—assessed the current impact of these antibiotic-resistant infections and the 10-year projection of their impact. The diseases were ranked as either urgent threats, serious threats or concerning threats using seven INFECTIOUS DISEASES E M E R G I N G T H R E A T S SINCE 1970s 40 INFECTIOUS DISEASES DISCOVERED —INCLUDING— SWINE and AVIAN FLU MERS and SARS Source: World Health Organization (WHO) 6 EMERGING AND RE-EMERGING INFECTIOUS DISEASES Infectious diseases have been emerging and reemerging causing great suffering for centuries. Greek, Roman and Persian civilizations documented new epidemics and the bubonic plague or “Black Death” in the 14th century killed a third of the population in Europe. In recent times, the most startling example of an emerging infectious disease has been HIV/AIDS. Emerging infectious diseases include previously unknown infectious agents, known agents that have spread to new populations and locations, known agents whose role in disease is only now understood, and the re-emergence of infectious diseases that had previously declined signiﬁcantly, but are now on the rise. Current emerging and re-emerging threats according to NIAID include: anthrax, antimicrobial resistance, botulism, campylobacteriosis, dengue fever, ehrlichiosis, E. coli, group A streptococcal infections, hepatitis, inﬂuenza, Lyme disease, plague, Prion diseases, SARS, salmonellosis/ shigella, smallpox, tuberculosis, tularemia, and West Nile virus. factors to determine an infection’s rank, including health impact, economic impact and how common the infection is, among others. Urgent Threats—Clostridium difﬁcile, carbapenem-resistant enterobacteriaceae (CRE), drug-resistant Neisseria gonorrhoeae. Serious Threats—Multidrug-resistant Acinetobacter, drugresistant Campylobacter, ﬂuconazole-resistant Candida, extended spectrum β-lactamase producing enterobacteriaceae (ESBLs), vancomycin-resistant Enterococcus (VRE), multidrug-resistant Pseudomonas aeruginosa, drug-resistant non-typhoidal Salmonella, drug-resistant Salmonella Typhi, drug-resistant Shigella, methicillin-resistant Staphylococcus aureus (MRSA), drug-resistant Streptococcus pneumoniae, drug-resistant tuberculosis. Concerning Threats—Vancomycin-resistant Staphylococcus aureus (VRSA), erythromycin-resistant Group A Streptococcus, clindamycin-resistant Group B Streptococcus. Medicines in Development Infectious Diseases 2013

Facts Facts About Infectious Diseases Bacterial Infections • In the United States, incidence of naturally-acquired anthrax is extremely rare—about 1-2 cases of cutaneous disease per year.1 INFECTIOUS VACCINATION FOR PREVENTION hepatitis A NOW PREVENTABLE hepatitis B NOW PREVENTABLE • More than 1.2 million cases of bacterial meningitis are estimated to occur each year worldwide. Without treatment, the fatality rate can be as high as 70 percent.1 • Bacterial vaginosis is the most common cause of vaginal infection among women, with an estimated 21.2 million women aged 14 – 49 affected in the United States.1 • About 3 million cases of C. difﬁcile infection diarrhea and colitis occur each year in the United States.2 About 14,000 deaths are attributed to the infection each year.1 DISEASES cancer caused by viruses NOW PREVENTABLE pneumonia NOW PREVENTABLE TARGETED FOR ELIMINATION rubella TARGETED FOR ELIMINATION measles TARGETED FOR ELIMINATION ERADICATED polio smallpox Source: PhRMA 2013 Vaccine Fact Book • Gram-negative bacteria are responsible for more than 30 percent of hospital-acquired infections and predominate in hospital-acquired pneumonia.3 • Impetigo—the most common bacterial skin infection and the third most common skin disease among children— accounts for approximately 10 percent of skin problems observed in pediatric clinics.4 • Otitis externa affects 4 in 1,000 people annually in the United States.5 • In 2011, sepsis/septicemia was the 11th leading cause of death overall in the United States. Between 20 percent and 50 percent of patients with sepsis die.1 ADDRESSING UNMET NEED FOR NEW ANTIBACTERIAL TREATMENTS Bringing new antibacterial treatments to market is a challenging process. A Lancet article published this year ﬁnds several obstacles for developing antibacterials and proposes the implementation of development scenarios within the existing regulatory system that would allow for either disease-based or pathogen-based label indications that would promote the most appropriate use of the new therapeutic and would facilitate a sustainable research and development structure. Medicines in Development Infectious Diseases 2013 • More than 11,000 tuberculosis cases were reported in the United States in 2010.1 • Urinary tract infections (UTIs) account for nearly 7 million ofﬁce visits and 1 million emergency department visits, resulting in 100,000 hospitalizations.2 • The estimated annual cost of community-acquired UTIs is approximately $1.6 billion.2 • Nearly 2 million people in the United States acquire an infection while in a hospital (nosocomial) each year, resulting in 90,000 deaths. More than 70 percent of the bacteria that cause these infections are resistant to at least one of the antibiotics commonly used to treat them.1 • Antibiotic resistance in the United States costs more than an estimated $20 billion a year in health care costs, $35 million in other societal costs, and more than 8 million additional days that people spend in the hospital.1 Fungal Infections • Candida fungal infections account for approximately 15 percent of all hospital-acquired infections, more than 72 percent of all hospital-acquired fungal infections, and up to 15 percent of all hospital-acquired bloodstream infections.4 7

Facts • Volvovaginal candidiasis accounts for about one-third of vaginitis cases. Nearly 50 percent of premenopausal women report having had at least one episode.6 • Onychomycosis is estimated to be responsible for up to 50 percent of all nail diseases.4 Parasitic Infections estimated 20 million people are currently infected, and an estimated 6.2 million new HPV infections occur annually.1 • Cervical cancer can be caused by certain types of HPV. In 2013, about 12,340 new cases of cervical cancer are estimated to occur in the United States, and some 4,030 women will die.1 • Between 6 million and 12 million head lice (pediculosis) infestations occur each year in the United States among children 3 to 11 years of age.1 • About $4 billion are spent annually on the management of conditions from HPV infections, exceeding the economic burden of any other sexually transmitted infection except HIV.1 • Leishmaniasis currently threatens 350 million men, women and children in 88 countries around the world. If left untreated, the fatality rate for visceral leishmaniasis in developing countries can be as high as 100 percent within 2 years.7 • The CDC estimates that pandemic H1N1 inﬂuenza virus in 2009 caused more than 60 million Americans to become ill and led to more than 270,000 hospitalizations and 12,500 deaths.1 • More than 3 billion people (half the world’s population) live in areas at risk of malaria transmission in 106 countries and territories. Worldwide, in 2010, there were 216 million cases of malaria and 655,000 deaths. About 86 percent of deaths globally were in children, and an estimated 91 percent of deaths in 2010 were in the African Region.1 • Although the incidence of inﬂuenza can vary widely between years, approximately 36,000 deaths and more than 200,000 hospitalizations are directly associated with inﬂuenza every year in the United States.8 Viral Infections • At least 60 percent of the U.S. population has been exposed to cytomegalovirus (CMV), with a prevalence of more than 90 percent in high-risk groups (e.g., unborn babies whose mothers become infected with CMV during pregnancy or people with HIV).4 • An estimated 700,000 to 1.4 million people in the United States are chronically infected with hepatitis B.1 • Hepatitis C virus infection is the most common chronic blood-borne infection in the United States; approximately 3.2 million persons are chronically infected.1 • At least 50 million people have genital herpes (caused by the herpes simplex virus) in the United States.6 • Approximately 5.6 million cases of pneumonia occur annually in the United States. In 2001, inﬂuenza and pneumonia together were the eighth leading cause of death in the United States.4 • Each year, up to 5 million children younger than age 4 acquire a respiratory syncytial virus (RSV) infection, and more than 125,000 are hospitalized in the United States because of it.4 Sources: 1. U.S. Center for Disease Control and Infection, www.cdc.gov 2. National Center for Biotechnology Information, National Institutes of Health, www.ncbi.nlm.nih.gov 3. The New England Journal of Medicine, Massachusetts Medical Society, www.nejm.org 4. Medscape, www.emedicine.medscape.com • The CDC estimates that 1,148,200 people ages 13 years and older are living with HIV infection, including 207,600 who are unaware of their infection. In 2011, an estimated 49,273 people were diagnosed with HIV infection in the United States.1 5. Epocrates, online.epocrates.com • Human papillomavirus (HPV) infection is the most common sexually transmitted infection in the United States. An 8. Medical News, www.news-medical.net 8 6. Wolters Kluwer Health, UpToDate, Inc., www.uptodate.com 7. World Health Organization, www.who.int Medicines in Development Infectious Diseases 2013

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